Adult spinal deformity
Conditions
Interventions
Use of the GEM-power cable system in adult spinal deformity surgery
Sponsors
MaastrichtUMC+
Eligibility
Inclusion criteria
Inclusion criteria: • Signed and dated written informed consent prior to admission to the clinical investigation in accordance with good clinical practice (GCP) and local legislation • Male or non-pregnant females • > 50 years of age • Adult spinal deformity determined as an abnormality of spinal alignment in the axial, coronal or sagittal plane [1], amenable for surgical treatment • Planned surgical instrumented spinal fusion of > 4 levels (> 5 vertebrae) • Body Mass Index index (BMI) < 40 kg/m2
Exclusion criteria
Exclusion criteria: • Patients with metal allergy/intolerance • Patients with compromised anatomical integrity of the laminar arch or a previous spinal surgery which may have compromised the integrity of the laminar arch (i.e. laminectomy) at proximal construct levels. • Previous spinal deformity correction surgery • Patients with any form of kidney dysfunctioning • Female patients that are pregnant or plan to become pregnant • Patients unwilling to cooperate with the study protocol and follow up schedule • Patients judged by the surgeon mentally incapable to follow study requirements • Patients with neuromuscular or neuro-sensory deficit which would limit the ability to assess the performance of the device • Diagnosed with active malignancy • Active alcohol or drugs abuser as defined by currently undergoing treatment for this abuse or as judged by the surgeon is likely to interfere with protocol compliance • Known systemic or metabolic disorders leading to progressive bone deterioration except patients with osteoporosis with a T-score of minimal -3.5 (below -3.5 is exclusion) • Use of systemic corticosteroids within the last 3 months ( inhaled steroids are no reason for exclusion) • presence of an active or suspected infection • Chronic disease that compromises the immune system (e.g. known HIV or known hepatitis). • Uncontrolled diabetes mellitus as determined by treating physicians • Participation in an ongoing investigational drug or device trial that has not completed the follow-up period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the Safety of the GEM-power cable system in adult spinal deformity patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical performance of the use of the GEM-power cable in spinal deformity surgery expressed as maintenance of spinal correction evaluation of pain and quality of life | — |
Contacts
Public ContactLiesbeth Jutten
Maastricht UMC+
Outcome results
None listed